BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED

    MDR report key: 3181750 · Received June 6, 2013

    Report

    Report Number
    2020362-2013-00258
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    May 16, 2013
    Manufacturer
    J. T. POSEY CO.
    Product Code
    OYS
    PMA / PMN Number
    K103817
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT CONFIRMED THAT THE PULL TAB IS MISSING ON THE END RAIL OF THE FOOT PANEL. HOWEVER, THERE IS A BROKEN SLIDER ON THE PATIENT ACCESS OF THE LEFT PANEL. NOTE: INSTRUCTIONS FOR USE STATE: NEVER USE THE BED IF A ZIPPER SLIDER IS BENT OPEN OR DAMAGED AND THE ZIPPER CANNOT BE ZIPPED COMPLETELY CLOSED. REMOVE THE PATIENT FROM THE DAMAGED BED AND EXCHANGE IT FOR A BED IN GOOD WORKING CONDITION. NEVER USE THE BED IF THE ZIPPER PULL-TAB IS MISSING OR BROKEN. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PULL TAB LOCATED ON THE PANEL IS MISSING. CUSTOMER DID NOT PROVIDE A DATE WHEN DISCOVERED. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251828 POSEY BED OYS J. T. POSEY CO. 8070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK